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Pilot Evaluation Comparing Regional Distribution of Ventilation During Lung Expansion Therapy

NCT03083379 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-06-14

Study results available
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Summary

The primary purpose of this study is to determine if there is a significant difference in regional distribution of ventilation when comparing eupneic tidal ventilation with Incentive Spirometry (I.S.) and EzPAP® lung expansion therapy in healthy adult human subjects. Electrical impedance tomography (EIT) will be used to measure regional distribution of ventilation during resting tidal ventilation and during lung expansion therapy.

Conditions

  • Ventilation
  • Breathing
  • Atelectasis

Interventions

DEVICE

Volumetric Incentive Spirometry

A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins. * Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences. * Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle. * Incentive Spirometry therapy and monitoring session will last about 15 minutes

DEVICE

EzPAP® POSITIVE AIRWAY PRESSURE

* A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only. * Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences. * Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause. * The 10-breath cycle will be repeated three times with respiratory therapist coaching. * Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle. * EzPAP® therapy and monitoring sessions will last about 15 minutes

Sponsors & Collaborators

  • Draeger Medical, Inc

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Daniel D Rowley, MSc RRT-ACCS · Pulmonary Diagnostics & Respiratory Therapy Servies, University of Virginia Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2017-04-21
Completion
2017-04-21
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03083379 on ClinicalTrials.gov